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Indian pharmaceutical companies are gearing up to become global suppliers of repurposed Covid-19 drugs. With the launch of new innovative Covid-19 oral drugs, Indian companies are again expected to grab opportunities in the global supply of oral Covid-19 drugs, according to data and analytics company GlobalData. As several countries witness increasing cases of Covid-19 despite vaccination, they have started booking supply orders for innovative Covid-19 treatments like antibody cocktails, monoclonal antibodies and the latest addition such Merck's the oral Covid-19 drug 'molnupiravir'. Prashant Khadayate, pharma analyst at GlobalData, comments: "Oral treatment for Covid-19 would be the most convenient option for the patients ranging from mild to moderate Covid-19 and would not require a hospital setting. Currently, a majority of the Covid-19 treatments require a hospital setting." According to GlobalData's Pharma Intelligence Center, the UK is the first country to approve molnupiravir which is in pre-registration stage in the US, EU and Japan.

The NHS on Thursday (May 5) said it has rolled out the arthritis drug baricitinib for seriously ill Covid patients. The Recovery trial, conducted by the NHS and University of Oxford, found that 13 per cent fewer severely ill patients died of Covid when treated with the drug compared to existing treatment options. Typically used to treat arthritis to reduce pain and inflammation, baricitinib can now be given to hospitalised Covid patients in addition to current treatments, and clinical studies show that this can provide benefits on top of existing treatment. The NHS has led the rollout of Covid medicines, from the discovery of dexamethasone as the world's first effective treatment, to the first vaccination outside of a clinical trial in December 2020. The NHS said baricitinib works by reducing inflammation caused by Covid-19 by blocking signals to the immune system that are causing it to attack the body.

Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7). Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics. The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc. Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December." Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.

Pfizer's oral Covid-19 therapy will be evaluated as a potential treatment for patients hospitalised with the illness in a major British trial, scientists said on Monday, as cases rise in some parts of the world. The world's largest randomised study of potential medicines for Covid-19, dubbed the RECOVERY trial, will assess Paxlovid across hospitals in Britain, which has already approved the drug for early-stage treatment. "Paxlovid is a promising oral antiviral drug but we don't know if it can improve survival of patients with severe Covid-19," said Peter Horby, a professor at the University of Oxford and joint chief investigator of the RECOVERY trial. The scientists said they aim to mainly find whether Pfizer's Paxlovid reduces the risk of death among patients admitted to hospitals with Covid-19.

UK regulator has approved a second oral antiviral for early treatment of Covid-19 in high-risk adults, after molnupiravir. The Medicines and Healthcare products Regulatory Agency (MHRA) gave its nod for a new treatment called Paxlovid (PF-07321332 and ritonavir), after finding it safe and effective at reducing the risk of hospitalisation and death in people diagnosed with mild Covid-19 infection. Developed by Pfizer, Paxlovid prevents the multiplying of virus, helping the body to overcome the infection. A clinical trial for the treatment in high risk individuals revealed that a five-days course of Paxlovid reduces the risk of hospitalisation and death by 89 per cent. It further revealed that Paxlovid is most effective when taken in the early stage of infection. Dr June Raine, MHRA chief executive, said: "We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage."

The National Institute for Health and Care Excellence (NICE) has issued draft guidance on 'Evusheld' which is not recommended for vulnerable adult with high risk of severe Covid-19 on Thursday (16 February). The draft guidance is open for public consultation until 9 March 2023. The committee will consider any comments received at a meeting currently due to take place on 4 April 2023. It comes after last month's decision by the US drug regulator to withdraw its emergency use authorisation for Evusheld as a preventative treatment for Covid-19, which said there was insufficient evidence that Evusheld is effective against the dominant variants of Covid-19 in the US. NICE's independent appraisal committee has reached the same conclusion having considered evidence which shows Evusheld is unlikely to prevent infection with most of the variants circulating in the UK now and in the near future. It has also announced that it is developing a new review process to update recommendations on the cost-effectiveness of Covid-19 treatments so they can be made available more quickly to patients if they show promise against new variants and are found to be cost-effective.

Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications. Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK. The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.

GlaxoSmithKline (GSK) says initial tests of the antibody-based Covid-19 therapy it is developing with US partner Vir suggest the drug is effective against the Omicron variant. A GSK statement on Thursday (December 2) said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail to work against viruses that were bio-engineered to carry a number of hallmark mutations of the new variant. The tests are continuing to confirm the results against all of the Omicron mutations, with an update expected by the end of the year, it added. The antibody is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high amount of mutations on that protein. "Sotrovimab was deliberately designed with a mutating virus in mind," said Vir chief executive George Scangos, adding that the drug was targeting a region of the spike protein that was highly unlikely to mutate.

Thirty-five generic drug manufacturers will make a more affordable version of Pfizer's anti-Covid pill for the world's poorer nations, in licensing deals announced Thursday (17) by a UN-backed organisation. The global Medicines Patent Pool (MPP) signed agreements with three dozen manufacturers to produce the oral Covid-19 treatment nirmatrelvir for supply in 95 low- and middle-income countries. US pharmaceutical giant Pfizer signed a licence agreement with the MPP in November. The MPP, in turn, issued sub-licences to the generic drugs makers. The deals announced Thursday will "help ensure access to our oral Covid-19 treatment for patients in need around the world", said Pfizer chairman Albert Bourla.

An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights for Covid-19 interventions between the pharmaceutical industry and developing nations endures. At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected. In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck. The declaration is not legally binding. However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.

Global demand for Pfizer's oral Covid-19 antiviral treatment Paxlovid has been unexpectedly low due to complicated eligibility requirements, reduced testing, and potential for drug interactions, according to a media report. Demand also has been hampered by the perception that Omicron infections are not that severe. Paxlovid was expected to be a major tool in the fight against Covid after it reduced hospitalizations or deaths in high-risk patients by around 90 per cent in a clinical trial. Thousands of people still die from Covid-19 every week, even as global infections are far off their peak. And there are only a few proven antiviral treatments, of which Paxlovid is the most attractive. The others are Merck & Co's far less effective rival pill molnupiravir, and Gilead Sciences' intravenous remdesivir.

Britain has become the first country to approve a Codiv-19 vaccine that targets both the original and Omicron variant of the virus. Medicines regulator MHRA approved the so-called bivalent vaccine made by US drug company Moderna as a booster for adults. The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said. The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. "The first generation of Covid-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA chief executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."

Indian drugmaker Dr Reddy's Laboratories will launch its generic version of Merck's antiviral Covid-19 pill, molnupiravir, and price it at 35 rupees ($0.4693) per capsule, a company spokesperson said on Tuesday (January 4). The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77). In comparison, the treatment with Merck's pill in the United States costs $700. "Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of Covid-19," the company spokesperson said. India last week gave emergency use approval to along with two vaccines, as the country braces for a possible spike in coronavirus cases due to the rapidly spreading Omicron variant.

Britain called on Sunday (November 21) for international action on the issue of medical devices such as oximeters that work better on people with lighter skin, saying the disparities may have cost lives of ethnic minority patients during the Covid-19 pandemic. Health secretary Sajid Javid said he had commissioned a review of the issue after learning that oximeters, which measure blood oxygen levels and are key to assessing Covid patients, give less accurate readings for patients with darker skin. "This is systemic across the world. This is about a racial bias in some medical instruments. It's unintentional but it exists and oximeters are a really good example of that," Javid said during an interview with the BBC. Asked whether people may have died of Covid-19 as a result of the flaw, Javid said: "I think possibly yes. I don't have the full facts." He said the reason for the discrepancies was that a lot of medical devices, drugs, procedures and textbooks were put together in white majority countries.

The British scientists behind one of the major therapeutic Covid-19 trials have turned their focus to treatments for monkeypox, a viral disease that has been labelled a global health emergency by the World Health Organization. The team from Oxford University behind the so-called RECOVERY trial - which honed in on four effective Covid treatments - on Tuesday unveiled a new trial, dubbed PLATINUM, to confirm whether Siga Technologies' tecovirimat is an effective treatment for monkeypox. Although there are vaccines developed for the closely related smallpox that can reduce the risk of catching monkeypox, there are currently no treatments that have been proven to help hasten recovery in those who develop the disease. The UK has over 3,000 confirmed cases of monkeypox. The virus is transmitted chiefly through close contact with an infected person. It typically causes mild symptoms including fever, rash, swollen lymph nodes and pus-filled skin lesions. Severe cases can occur, though people tend to recover within two to four weeks. Siga's drug, branded Tpoxx, has been cleared to treat diseases caused by the family of orthopoxvirus that includes smallpox, monkeypox and cowpox by the European Union and United Kingdom, but due to limited trial data it is generally only used in severe cases in Britain.

More than 1.5 million courses of Pfizer's COVID-19 antiviral drug Paxlovid have expired unused in European countries by the end of November, the health analytics firm Airfinty has revealed. It is predicted that the figure could surge to 3.1 million, at a value of $2.2 billion (around £1.73 billion), by the end of Feb 2024. According to Airfinty analysis, Britain has the highest unused stock, with an estimated one million expired drug courses worth $700 million (over £550 million). With 2.2 million courses estimated to expire unused by the end of June 2024 due to the low prescription of the antiviral in the country, the total drug value wasted in the UK could reach $1.5 billion (£1.1 billion), the report added.

From over-the-counter flu tablets to crucial antibiotics and antidepressants, medicines are running scarce in UK pharmacies this year, causing concerns among patients, the government, and the wider pharma industry. Drug shortages have accelerated over the past year due to a clutch of problems including the after-effects of the pandemic on supply chains, the war in Ukraine, and soaring input costs weighing on manufacturers. More recently, a sudden spike in respiratory infections - another by-product of Covid-19 that neither pharma companies nor the government were able to predict - has deepened the crisis, with 70 commonly taken drugs out of stock in Britain as of February. The problem is not unique to the UK. In a recent survey of groups representing pharmacies in 29 European countries, three quarters said shortages were worse this winter than a year ago, with a quarter reporting more than 600 drugs in short supply. The US is also facing significant shortages of popular prescription drugs like amoxicillin and Adderall, an ADHD medication. To some extent, the current disruption is laying bare wider challenges facing the industry for several years that were only exacerbated by the pandemic. The over-reliance on foreign suppliers for most active pharmaceutical ingredients (APIs) is one of them. This model has left companies more susceptible to supply shocks, which have in turn increased in frequency and severity due to pandemic lockdowns, the war in Ukraine and other issues such as the shortage of shipping containers. Pharma's long and opaque supply chains, alongside regulatory complexities, also mean it is taking longer for drugmakers to reconfigure manufacturing and distribution in times of additional need.

British drugmaker GSK said on Tuesday (December 7) its antibody-based Covid-19 therapy with US partner Vir Biotechnology is effective against all mutations of the new Omicron coronavirus variant, citing new data from early-stage studies. The data, yet to be published in a peer-reviewed medical journal, shows that the companies' treatment, sotrovimab, is effective against all 37 identified mutations to date in the spike protein, GSK said in a statement. Last week, another pre-clinical data showed that the drug had worked against key mutations of the Omicron variant. Sotrovimab is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high number of mutations on that protein. "These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO," GSK chief scientific officer Hal Barron said.

Covid-vaccine maker AstraZeneca said Friday that profits fell sharply in the first half on ballooning costs linked to its takeover of US biotech firm Alexion. The pharmaceutical group added that sales of its Covid-19 vaccine Vaxzevria slumped 49 percent in the second quarter. Net profit slumped 64 per cent to $746 million compared with the first six months of last year, AstraZeneca said in a statement. Operating expenses jumped 33 percent, "reflecting the addition of Alexion, and continued investment in new launches and the pipeline" of drugs, the group said. That offset a 48-percent jump in revenue to more than $22 billion. Revenue rose strongly thanks to sales of Alexion medicines. The group said annual revenue from Covid-19 medicines is anticipated to be broadly flat compared with 2021.

CMS released payment allowances for two COVID-19 related billing codes. The codes account for the injection, infusion, and post-administration monitoring of the FDA- approved COVID-19 antibody drug.